Sequenced Treatment Alternatives to Relieve Depression (STAR*D)
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Purpose
STAR*D focuses on non-psychotic major depressive disorder in adults who are seen in outpatient settings. The primary purpose of this research study is to determine which treatments work best if the first treatment with medication does not produce an acceptable response. Participants will first receive citalopram, an SSRI medication; if symptoms remain after 8-12 weeks of treatment, up to four other levels of treatment will be offered, including cognitive therapy and other medications. There are no placebo treatments. Some patients may require a combination of two or more treatments to obtain full benefit. Participation could last from 15 to 27 months and involve up to 30 clinic visits. Participants will be interviewed by telephone throughout the study about their symptoms, daily functioning, treatment side effects, use of the health care system, and satisfaction with treatment. There will be a one-year follow up for participants once their depression has been successfully treated
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: citalopram Drug: BuproprionSR Drug: buspirone Drug: Lithium Drug: mirtazapine Drug: nortriptyline Drug: sertraline Drug: tranylcypromine Drug: VenlafaxineXR Behavioral: Cognitive Therapy Drug: T3 (Triiodothyronine) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sequenced Treatment Alternatives to Relieve Depression |
| Estimated Enrollment: | 4000 |
| Study Start Date: | July 2001 |
| Estimated Study Completion Date: | September 2006 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- Outpatients aged 18 to 75 years old with nonpsychotic major depressive disorder (HAMD score 14 or greater)
Contacts and Locations
Show 41 Study Locations| Study Director: | A. John Rush, MD | University of Texas Southwestern Medical Center Department of Psychiatry |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00021528 History of Changes |
| Other Study ID Numbers: | N01 MH90003, DSIR AT |
| Study First Received: | July 20, 2001 |
| Last Updated: | September 24, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Sequential Treatment Major Depression Treatment Resistant Depression |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Citalopram Sertraline Nortriptyline Tranylcypromine Mirtazapine Dexetimide Buspirone Lithium Antidepressive Agents, Second-Generation Antidepressive Agents |
Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013